ClinicalTrials.gov
ClinicalTrials.gov Menu

Surveillance Study of Women Taking Intrinsa® (EMPOWER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00551785
Recruitment Status : Terminated (The marketing authorization for Intrinsa was withdrawn.)
First Posted : October 31, 2007
Last Update Posted : March 25, 2015
Sponsor:
Collaborator:
Procter and Gamble
Information provided by (Responsible Party):
Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany

Brief Summary:
The primary objective of the study is to assess the risks of testosterone transdermal patch use in a representative study population. The primary clinical outcome of interest is breast cancer.

Condition or disease
Ovariectomy Hysterectomy Hypoactive Sexual Desire Disorder

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 328 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Multinational Postmarketing Observational Study of Women Prescribed Intrinsa
Study Start Date : September 2007
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
1
Women prescribed Intrinsa and estrogen therapy
2
Women prescribed estrogen therapy



Primary Outcome Measures :
  1. gynecological cancer; serious cardiovascular diseases [ Time Frame: Time to event analysis within 8 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women prescribed estrogen therapy or estrogen therapy in combination with Intrinsa
Criteria

Inclusion Criteria:

  • All women with bilateral oophorectomy and hysterectomy who receive a new prescription for the study medication or who were prescribed it for a period of six months or less before study entry

Exclusion Criteria:

  • Women who at baseline have used Intrinsa® or the new estrogen therapy for more than six months
  • Women who do not consent to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551785


Locations
Germany
Center for Epidemiology and Health Research
Berlin, Germany, 10115
Sponsors and Collaborators
Center for Epidemiology and Health Research, Germany
Procter and Gamble
Investigators
Principal Investigator: Klaas Heinemann, MD, PhD Center for Epidemiology and Health Research, Germany

Responsible Party: Klaas Heinemann, MD, PhD, Principal Investigator, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT00551785     History of Changes
Other Study ID Numbers: ZEG2007_01
First Posted: October 31, 2007    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015

Keywords provided by Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany:
Hypoactive Sexual Desire Disorder
Menopause
Androgen

Additional relevant MeSH terms:
Hypokinesia
Sexual Dysfunctions, Psychological
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders
Methyltestosterone
Testosterone 17 beta-cypionate
Testosterone
Testosterone enanthate
Testosterone undecanoate
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgens